The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: DME; Dental; Dental Caries; Deep Margin Elevation

• Registration Number: NCT06900868
• Lead Sponsor: Future University in Egypt

Brief Summary

Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent caries, particularly at the gingival margin(Imazato et al. 2023). The antibacterial and antifungal effects help inhibit biofilm formation, enhancing the longevity of restorations. Additionally, these materials support better marginal adaptation by reducing microleakage and improving bond durability (Imazato et al. 2023) This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health(Imazato et al. 2023).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-20
• Study First Submitted: 2025-03-22
• Study First Submitted QC: 2025-03-22
• Last Update Submitted: 2025-03-22
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-04-20
• Study Completion: 2026-04-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adults patients (20-50)
• Good oral hygiene (plaque index 0 or 1 )
• Patient approving to participate in the study
• Absence of parafunctional habits and/or bruxism
• No sign of irreversible pulpitis
• No periapical radiolucency
• Deep subgingival margin
• Molars class II with subgingival margin

Exclusion Criteria

• • Patients with known allergic or adverse reaction to the tested materials.

  • Systematic disease that may affect participation.
  • Xerostomic patients.
  • Bad oral hygiene (plaque index 2 or 3 )
  • Heavy smokers
  • Patients undergoing or will start orthodontic treatment
  • Patients with removable prothesis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recurrent caries	T0: 1 Week Baseline T1: 6 Months T2: 12 Months	* 0: no evidence of caries continuous along the margin using periapical radiograph.; * 1: caries evident continuous with the margin of restoration

Secondary Outcome Measures

Name	Time	Method
Fracture of Restoration	T0: 1 Week Baseline T1: 6 Months T2: 12 Months	* 1: Restoration is intact and fully retained.; * 2:Restoration is partially retained with some portion of the restoration still intact.; * 3:Restoration is completely missing
Post- operative sensitivity	T0: 1 Week Baseline T1: 6 Months T2: 12 Months	* 1: Absent; * 2: Present
Bleeding on Probing	T0: 1 Week Baseline T1: 6 Months T2: 12 Months	* 0 :Healthy gums; * 1 :Bleeding on probing